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Trial record 1 of 1 for:    NCT03460574
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Targeting Cognitive Immunization in Depression

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ClinicalTrials.gov Identifier: NCT03460574
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

Tracking Information
First Submitted Date  ICMJE January 29, 2018
First Posted Date  ICMJE March 9, 2018
Last Update Posted Date August 23, 2018
Actual Study Start Date  ICMJE October 14, 2017
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
Performance Expectations Scale - generalized [ Time Frame: Directly prior to the performance test and directly after completing the performance test ]
Change from Baseline to Postassessment in generalized performance expectations
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
Performance Expectations Scale - generalized [ Time Frame: Directly prior to the performance test and directly after completing the performance test ]
Pre to post change in generalized performance expectations
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
Performance Expectations Scale - task-specific [ Time Frame: Directly prior to the performance test and directly after completing the performance test ]
Change from Baseline to Postassessment in task-specific performance expectations
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
Performance Expectations Scale - task-specific [ Time Frame: Directly prior to the performance test and directly after completing the performance test ]
Pre to post change in task-specific performance expectations
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Targeting Cognitive Immunization in Depression
Official Title  ICMJE How Can Change of Dysfunctional Expectations in Major Depression be Enhanced? An Experimental Study Targeting Cognitive Immunization
Brief Summary Research has shown that people suffering from MDD tend to maintain dysfunctional expectations despite experiences that disconfirm expectations. Recently, it has been shown that this persistence of expectations is due to maladaptive information processing involving "cognitive immunization". This experimental study aims at testing three different strategies to inhibit cognitive immunization, in order to enhance expectation change.
Detailed Description It appears adaptive to change one's expectations when continuously gaining expectation-disconfirming experiences; however, research has shown that people suffering from MDD have difficulty in changing their expectations after experiences that disconfirm expectations. Recently, the investigators have shown that this persistence of expectations is due to maladaptive information processing involving "cognitive immunization", defined as a cognitive reappraisal of expectation-disconfirming experiences in such a way that the individual's expectations are maintained. In view of psychotherapeutic interventions aiming to modify patients' dysfunctional expectations, effective strategies to inhibit cognitive immunization strategies need to be identified. Therefore, the aim of this study was to compare different immunization-inhibiting strategies with regard to their effectivity in enhancing expectation change. For this purpose, the investigators use a standardized experimental paradigm, which was developed and validated in a previous study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment Participants are assigned to one of four experimental groups in parallel for the duration of the study
Masking: Single (Investigator)
Masking Description:
The investigator randomly assigns participants to one of the experimental conditions. Participants are not aware which experimental condition they are allocated to.
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Behavioral: INFORMATION
    After receiving expectation-disconfirming positive performance feedback, participants receive standardized information that stresses the relevance of this experience. In particular, participants are told that the performance test they worked on is highly relevant for both professional success and personal life satisfaction.
  • Behavioral: SALIENCE
    After receiving expectation-disconfirming positive performance feedback, partcipants in this condition are instructed to remember how well they performed on the performance test. Using a visual analogue scale, they were asked to specify how they performed relative to the other participants.
  • Behavioral: ATTENTION
    Before working on the performance test, participants are instructed to pay attention to the feedback they receive. In particular, they are asked to enter what would be a personally good result for them. It is supposed that this shift of attention increases the salience of the expectation-disconfirming feedback.
  • Behavioral: CONTROL
    This group does not receive any further intervention. Instead, participants of this group pass through the standard procedure of the EXPEC paradigm.
Study Arms  ICMJE
  • Experimental: INFORMATION
    Participants in this condition receive a manipulation suggesting that the performance test "TEMINT", they previously worked on, has been shown to be highly relevant for daily life and professional success. We anticipated that after receiving this fake information about the TEMINT, it would be difficult for participants to engage in cognitive immunization processes because the validity and utility of the expectation-disconfirming experience is explicitly highlighted.
    Intervention: Behavioral: INFORMATION
  • Experimental: SALIENCE
    Participants in this condition are asked to think about how well they performed on this really difficult performance test. We anticipated that this manipulation would enhance expectation change, as the salience of the expectation-disconfirming experience was explicitly increased.
    Intervention: Behavioral: SALIENCE
  • Experimental: ATTENTION
    Before working on the performance test, participants in this conditions receive the instruction to attentionally focus on their personal result in the performance test. Further, they are asked to specify what would be personally good result for them. We anticipated that after receiving this instruction, the expectation-disconfirming performance feedback should be salient for the participants, hence making it difficult for them to engage in cognitive immunization strategies.
    Intervention: Behavioral: ATTENTION
  • Experimental: CONTROL
    Participants in this condition receive no further information. Therefore, they are passing through the standard procedure of the previously developed experimental paradigm.
    Intervention: Behavioral: CONTROL
Publications * Kube T, Rief W, Gollwitzer M, Glombiewski JA. Introducing an EXperimental Paradigm to investigate Expectation Change (EXPEC). J Behav Ther Exp Psychiatry. 2018 Jun;59:92-99. doi: 10.1016/j.jbtep.2017.12.002. Epub 2017 Dec 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2018)
135
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2018)
112
Actual Study Completion Date  ICMJE August 21, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • current diagnosis of Major Depressive Disorder
  • at least 18 years old
  • sufficient German language knowledge

Exclusion Criteria:

- none

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03460574
Other Study ID Numbers  ICMJE 2017-39k
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD will be shared
Responsible Party Philipps University Marburg Medical Center
Study Sponsor  ICMJE Philipps University Marburg Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tobias Kube, M. Sc. Philipps University Marburg Medical Center
PRS Account Philipps University Marburg Medical Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP